Recall record at a glance
| Official record | Z-0599-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Report date | Dec 11, 2024 |
| Recall initiation date | Oct 21, 2024 |
| Quantity | 11330 units |
| Location | Tarrytown, NY, United States |
Official product description
Atellica CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635
Why the product was recalled
Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH ¿2-Microglobulin (B2M) reagent.
Distribution information
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Ivory Coast, Japan, Jordan, Kuwait, Mexico, Morocco, Oman, P.R. China, Pakistan, Paraguay, Poland, Portugal, Saudi Arabia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, U.A.E., Uganda, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zaire.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: not stated.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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